Full Title

A Phase 1/2 Dose Escalation and Cohort Expansion Study of the Safety and Tolerability of Urelumab Administered in Combination with Nivolumab in Advanced /Metastatic Solid Tumors and B Cell Non-Hodgkins Lymphoma

Purpose

The purpose of this study is to find the highest dose of the investigational drug urelumab that can be given with nivolumab in patients with advanced solid tumors or B-cell non-Hodgkin lymphoma (NHL) that continues to grow despite standard treatment. Urelumab is an antibody which recognizes a protein on immune cells called CD137. By binding to CD137, urelumab may stimulate patients’ immune cells to attack their cancer cells.

Nivolumab is a form of immunotherapy. It boosts the body’s immune system by targeting a protein on white blood cells called PD-1. PD-1 normally maintains the balance of the immune system by shutting it down at the right time. Some cancers take advantage of this mechanism by expressing PD-L1, enabling them to escape attack by the body’s white blood cells. Nivolumab blocks PD-1, enhancing the body’s ability to detect and destroy cancer cells. It is approved for treating several types of cancer; its use in this study is considered investigational.

Doctors hope that by combining urelumab and nivolumab, the immune response against cancer will be stronger than with either drug used alone. Both drugs are given intravenously (by vein).

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

Patients must have an advanced/metastatic solid tumor or B-cell NHL which has continued to grow despite standard therapy.

At least 4 weeks must pass between completion of prior cancer therapy and entry into the study.

Patients must be physically well enough that they are fully ambulatory, capable of all self care, and are capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.

This study is for patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact the office of Dr. Neil H. Segal at 646-888-4187.